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Completed

NCT Number: NCT01287390

Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck

Severe acute and late dysphagia is now considered as a dose-limiting toxicity of radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of life. We propose to preserve swallowing function by:

* adapting (individualizing) treatment (intensity-modulated radiotherapy: IMRT) to per-treatment changes occurring in the tumor and surrounding organs and tissues; * reducing the volumes of elective neck, that may result in significant decrease of severe acute and late dysphagia.

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Key information

Conditions

Primary Non-operated Squamous Cell Carcinoma of Oral Cavity Carcinoma Carcinoma, Squamous Cell Laryngeal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Otorhinolaryngologic Diseases Primary Non-operated Squamous Cell Carcinoma of Hypopharynx Primary Non-operated Squamous Cell Carcinoma of Larynx Primary Non-operated Squamous Cell Carcinoma of Oropharynx Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Ghent, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
  • Primary non-resected tumor and/or patients refused surgery
  • Stage T1-4, N0-3; for cancer of the glottis T3-4 or T any N1-3
  • Decision of curative radiotherapy or radiochemotherapy made by a Multidisciplinary Group of Head and Neck Tumors at UZ Gent and UZ Gasthuisberg Leuven
  • Karnofsky performance status >= 70 %
  • Age >= 18 years old
  • Informed consent obtained, signed and dated before specific protocol procedures

Exclusion criteria

  • Treatment combined with brachytherapy
  • Prior irradiation to the head and neck region
  • Surgery of the primary tumor except lymph node dissection prior to radiotherapy
  • induction chemotherapy
  • history of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years
  • Distant metastases
  • Creatinine clearance (Cockroft-Gault) =< 60 milliliter/minute before treatment or creatinine value > 1,3 milligram/deciliter
  • Known allergy to the CT-contrast agents
  • Pregnant or lactating women
  • Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
  • Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study

Treatment and study plan

video fluoroscopy

Procedure

video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up

extra imaging

Procedure

For tumor response, 2 extra CT or Fludeoxyglucose (18F)-Positron Emission Tomography (PET)/Computed Tomography (CT), and/or Magnetic Resonance Imaging (MRI) will be performed.

scoring acute toxicity

Other

Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.

scoring of late toxicity

Other

Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.

scoring quality of life (QOL)

Other

Quality of life is scored with the Quality of Life Questionnaire of the 'European Organisation for Research and Treatment of Cancer' (EORTC QOL-C30) and the Head and Neck Cancer Specific Quality of Life Questionnaire (QLQ-H&N 35).

Primary outcomes

  1. Reduction of acute and late treatment-induced dysphagia

    Time frame: after 1 year

    Reduction of the rates of acute and late treatment-induced dysphagia with experimental treatment as compared to standard treatment.

Secondary outcomes

  1. acute treatment-induced toxicity

    Time frame: weekly during treatment

  2. late treatment-induced toxicity

    Time frame: after 1, 3, 6, 9 and 12 months

  3. tumor response: imaging

    Time frame: after 3 months

  4. tumor response: clinical examination

    Time frame: after 1, 3, 6, 9 and 12 months

  5. local, regional and distant control: imaging

    Time frame: after 3 months

  6. local, regional and distant control: clinical examination

    Time frame: after 1,3, 6, 9 and 12 months

  7. local, regional and distant control: biopsy

    Time frame: from 3 months on

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck: a Multicenter, Two-arm, Randomized Phase II Trial.

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Feb 1, 2011
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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